'Covishield safe, incident with volunteer no way induced by vaccine': Serum Institute
New Delhi, Dec 01: Vaccine major Serum Institute of India (SII) said on Tuesday that its vaccine candidate for the coronavirus disease (Covid-19) is "safe and immunogenic".
A 40-year-old man who took part in the ''Covidshield'' vaccine trial in Chennai has alleged serious side effects, including a virtual neurological breakdown and impairment of cognitive functions and has sought Rs 5 crore compensation in a legal notice to Serum Institute and others, besides seeking a halt to the trial.
"The COVISHIELD vaccine is safe and immunogenic. The incident with the Chennai volunteer though highly unfortunate was in no way induced by the vaccine and Serum Institute of India is sympathetic with the volunteer's medical condition," Serum Institute said in its statement.
"All regulatory, ethical processes and guidelines were followed by the company. The principal investigator DSMB (Data and Safety Monitoring Board) and ethics committee stated it was non-related issue to vaccine trial," it said.
Serum Institute rejected charges that a COVID-19 vaccine candidate has serious side effects, and threatened to seek heavy damages for "malicious" allegations.
"The allegations in the notice are malicious and misconceived. While the Serum Institute of India is sympathetic with the volunteer''s medical condition, there is absolutely no correlation with the vaccine trial and the medical condition of the volunteer," Serum Institute of India said in a statement.
The volunteer is falsely laying the blame for his medical problems on the COVID vaccine trial, it added.
"It is evident that the intention behind the spreading of such malicious information is an oblique pecuniary motive. The Serum Institute of India, will seek damages in excess of 100 crore for the same and will defend such malicious claims," Serum Institute said.
Pune-based Serum Institute of India (SII) has collaborated with Oxford University and pharmaceutial company Astra Zeneca for making the COVID-19 vaccine, ''Covidshield'', and is conducting trials in India.